Use of Public Health Surveillance Models in the French National Health System Database

Public health surveillance models, previously used for the ongoing detection of occurrence of rare events, could be used to reinforce existing pharmacovigilance systems. These models have not been previously used for Adverse Drug Reaction (ADR) detection in medico-administrative databases. DABISURV research project focuses on a new anticoagulant therapy, dabigatran, launched recently on the French market for atrial fibrillation (AF). This drug is at high risk for severe ADR and requires thus careful pharmacovigilance monitoring.

Primary objective is to compare the results of ongoing surveillance models to detect hemorrhages or acute myocardial infarction (AMI) associated with dabigatran, with the results obtained from the analysis of a cohort of patients with AF under the same treatment.

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Key information

Conditions

Atrial Fibrillation Anticoagulants Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pharmacoepidemiology

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Reunion Island

Saint-Denis, Reunion Island, 97400, France

About this study

DABISURV study consists in an analyze of a cohort of patients with AF who have received at least one prescription Vitamin K Antagonists (VKA) - reference group - or of dabigatran in the French National Health Insurance System.

The uptake of dabigatran is followed for detecting hemorrhagic events or AMI associated with this molecule among first users.

The ability to detect quickly substantial ADR of new drugs is of critical importance to public health in order to facilitate timely public health response. If the public health surveillance models are found useful for this topic, then semi-automated procedures would be needed to detect ADR associated with new generation anticoagulants in medico-administrative databases. If the public health surveillance models are found not useful for the detection of ADR, the cohort study itself will provide essential data on the safety profile of dabigatran.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with non-valvular atrial fibrillation
Patients receiving an first prescription of anticoagulants

Exclusion criteria

Patients with valvular atrial fibrillation

Treatment and study plan

dabigatran

Drug

Primary outcomes

results of ongoing surveillance models to detect hemorrhages or AMI (in frequency and proportion) associated with dabigatran or VKA for AF in a health database cohort of patients with AF treated by dabigatran or VKA

Time frame: 36 months

Propensity-matching is required for adequate comparison and multivariate regression

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de la Réunion

Other

Registry information

Official study title

Use of Public Health Surveillance Models in the French National Health System Database: A Tool for an Ongoing Monitoring of Adverse Drug Reaction? The Case of Dabigatran

Acronym: DABI-SURV

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2018
First posted: Sep 19, 2016
Registry last updated: Sep 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed